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Boekel Floor Standing Platelet Incubator Agitator

FDA UDI

Class II (US FDA UDI)

by Boekel Industries, Inc.

Identity

Trade Name
Boekel Floor Standing Platelet Incubator Agitator FDA UDI
Generic Name
Platelet incubator FDA UDI
Device Name
Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets. FDA UDI
Model / Reference
FS100 FDA UDI
Description
Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets. FDA UDI

Identifiers

Catalog Number
FS100 FDA UDI
Primary DI / UDI-DI
00863626000294 FDA UDI
FDA Product Code
KSH FDA UDI
GMDN Term
Platelet incubator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9575 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Platelet incubator

Boekel Floor Standing Platelet Incubator Agitator by Boekel Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Platelet incubator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boekel Industries, Inc.

Sources (1)

  • FDA UDI 47656414-9e06-45b9-a315-e4c84e0ca46d 34 fields · synced May 30, 2026